iPath for CP Pilot

Официальное название

Improving Screening and Access to Treatment for Depression in Care Partners of People Living With Dementia

Обзор

Depression is a significant problem in care partners of people living with dementia; despite the expansion of options for accessing evidence-based treatments, most care partners of people living with dementia are not screened for depression and do not receive treatment. The objective of this project is to identify a screening method for depression that is feasible and acceptable to care partners and to adapt an innovative pathway to online evidence-based treatment for depression (iPath\*D) as a means of increasing mental health literacy, screening rates and treatment access for care partners of people living with dementia. The results are expected to have a major positive impact by providing proof-of-principle for the use of an online pathway to evidence based treatment with the potential for reaching an unprecedented number of care partners who have unmet mental health needs.

Подробное описание

Depression affects up to 34% of care partners (CP) of people living with dementia (PLWD) each year and despite the expansion of treatments, most individuals do not receive treatment. Three key barriers to treatment exist: low detection, low mental health literacy (MHL) and limited treatment accessibility, exacerbated in rural settings. Innovative informatics solutions to barriers exist including automating screening, enhancing MHL through decision aids (DA) and increasing accessibility via location-independent, online treatments. Yet there is a gap in identifying strategies to screen and connect CP of PLWD with unmet mental health needs to treatments. The objective for this GEMSSTAR is to modify an innovative application, iPATH\*D, developed previously by the research team, for CP of PLWD. iPath\*D is an online platform that connects patients screening positive for clinically significant depression in rural cancer settings to a range of online and in-person evidence-based treatments. Investigators plan to adapt both the content and implementation of iPath\*D, then establish its acceptability, usability, and feasibility, overcoming the unique challenges to help-seeking CP of PLWD. The specific aims are: Aim 1. Optimize and assess feasibility and acceptability of a pathway to identify care partners of persons living with dementia at risk for depression; and Aim 2. Determine feasibility, acceptability, and usability of implementing iPath\*D with care partners of persons living with dementia and its preliminary impact on MHL, screening and treatment rates. The study tests the hypotheses that: (1) iPath\*D will be acceptable and highly usable and will demonstrate preliminary impact of increased MHL, screening rates and treatment access. The development of iPath\*D follows a user centered design model. In Aim 1 care partners (n=15) will co-design iPath\*D via participatory design activities to inform the adaptations needed to the design and functionality of iPath\*D, and development of low and high-fidelity iPath\*D prototypes, which will go through rounds of iterative development, with extensive usability evaluations, ensuring iPath\*D surpasses usability metrics. In Aim 2, an open label, single arm pilot, 15 care partners screening positive for depression will receive iPath\*D. Real world usability, acceptability and feasibility will be assessed, and preliminary data on MHL, rates of screening and treatment access, treatment initiation, adherence, change in caregiver burden, and depression symptom improvement will be gathered. This research is innovative in developing and testing a novel services delivery model (iPath\*D) that addresses existing barriers to care. The results are expected to have a major positive impact by providing proof-of-principle for the use of an online pathway to treatment with the potential for reaching an unprecedented number of individuals in rural settings with unmet mental health needs by understanding and implementing the optimal design of an innovative model of services delivery for CP of PLWD who experience depression.

Вмешательства

• Другое depression app for care partners of persons with dementia
  iPath\*CP is an app designed to screen for depression in care partners of persons with dementia, provide specific information about depression in care partners of persons with dementia, offers a decision aid to assist in deciding on treatment and also offers a curated list of potential treatment options, sortable by cost and time to access.

Первичные конечные точки

• Usability of Intervention [Срок оценки: Assessed after initial use of iPath app at T1 (2 weeks)]
• Acceptability of Intervention [Срок оценки: Assessed at end of study, T1 (2 weeks)]
• Feasibility of Intervention [Срок оценки: Assessed at end of study, T1 (2 weeks)]
• Appropriateness of Intervention [Срок оценки: Assessed at end of study, T1 (2 weeks)]
• Treatment access [Срок оценки: Assessed at end of study, T1 (2 weeks)]
• Mental health literacy [Срок оценки: Change between T0 and T1 (2 weeks)]

Вторичные конечные точки (5)

• PHQ-9 completion [Срок оценки: Assessed at T0 and at 2 weeks (T1)]
• Treatment initiation [Срок оценки: Assessed at end of study, T1 (2 weeks)]
• Treatment adherence [Срок оценки: Assessed at end of study, T1 (2 weeks)]
• Decisional regret [Срок оценки: Assessed at end of study, T1 (2 weeks)]
• Symptom monitoring - PHQ-9 [Срок оценки: Change across 2 week period]

Критерии участия

Критерии включения

• For 2 Week iPath\*CP Pilot:

• Adults (≥18 years)
• Care partners of persons with dementia who score ≥5 on the PHQ-8 AND PHQ-9 screen
• Can communicate in English
• Have access to an Android based or Apple iOS based phone or tablet capable of running the iPath application.

For Debrief Interviews:

• Care partners: Interviews will be conducted with a purposeful sample of 6 patients already consented into the study at the completion of T1 data collection, ensuring representation by sex (male/female), perceived usability (low/high) of iPath\*CP and race/ethnicity.
• Clinicians: Interviews will be conducted with clinicians and clinical staff who had patients involved in the project.

Критерии исключения

• Care partners with:

• PHQ-8 score <5
• Answering positively for question 9 of the PHQ-9 who also screen positive for suicidal ideation with method, intent, plan or a recent prior suicide/self-harm attempt, as determined by a positive endorsement of items 3, 4, 5 or 6b ("Past 3 Months") on the Columbia-Suicide Severity Rating Scale (C-SSRS) and determined by Dr. Mistler, Psychiatrist at DH, not to be eligible.
• With bipolar disorder or psychosis (documented in the electronic medical record \[EMR\])
• With significant cognitive impairment (documented in the EMR or self-reported during eligibility screening)
• With no access to an Android or Apple device

For Debrief Interviews:

• Patients: Participants withdrawn from the 2 Week iPath\*CP Pilot.
• Clinicians: None.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07631247 · STUDY02003455 · R03AG088962-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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